Regional interlaboratory standardization of determinations of cholesterol, high-density lipoprotein cholesterol, and triglycerides.
The Clinical Chemistry Forum of Central Virginia initiated a lipid standardization program to help ensure that its members meet the current National Cholesterol Education Program guidelines for cholesterol testing, and to standardize assays of high-density lipoprotein (HDL) cholesterol and triglycerides so as to provide accurate lipid profiles. We found that freshly collected, never-frozen human sera must be used to assess interlaboratory accuracy for cholesterol, HDL cholesterol, and triglycerides assays, and that at least 23 samples are required to detect a 3% bias with 90% power when the between-laboratory imprecision (CV) is 3%. After recalibration, all 12 laboratories had a mean HDL cholesterol bias less than or equal to 5%, nine of 10 laboratories had a mean HDL cholesterol bias less than or equal to 40 mg/L for samples with values less than or equal to 570 mg/L, and 10 of 12 laboratories had a mean triglycerides bias less than or equal to 10% for fresh human sera split between participants and the Centers for Disease Control. Pools of frozen human sera were shown to have matrix biases greater than 3% for cholesterol in seven of 11 laboratories, and greater than 40 mg/L for HDL cholesterol in six of nine laboratories.
Tetrault
G A
GA
Department of Pathology, Virginia Commonwealth University, Medical College of Virginia, Richmond 23298-0597.
Miller
W G
WG
Chinchilli
V M
VM
D001800:Blood Specimen Collection; D002624:Chemistry, Clinical / Q000592:standards*; D002784:Cholesterol / Q000097:blood* / Q000592:standards; D008076:Cholesterol, HDL / Q000097:blood* / Q000592:standards; D006801:Humans; D007753:Laboratories / Q000592:standards*; D009313:National Health Programs; D013048:Specimen Handling; D014280:Triglycerides / Q000097:blood* / Q000592:standards; D014768:Virginia
D008076:Cholesterol, HDL; D014280:Triglycerides; D002784:Cholesterol